With only a few exceptions, the RoHS Directive 2011/65/EU is one of the pieces of EU harmonisation legislation that applies to almost all electrical and electronic equipment placed on the market. A wide range of products, from consumer electronics and household appliances to IT equipment, lighting, tools and monitoring and control instruments, must comply with its requirements.
Then, for most manufacturers, the question is not whether their product is in the scope of the RoHS Directive but how to demonstrate it in a way that holds up in front of a market surveillance authority.
This is where harmonised standards come in, and for RoHS, there is currently one: EN IEC 63000:2018. In this post we look at what the Directive asks of manufacturers, what EN IEC 63000 covers, and why the hardest part of RoHS compliance usually starts after you have read the standard.
What RoHS requires from manufacturers
The core rule sits in Article 4: electrical and electronic equipment (EEE), including cables and spare parts, must not contain the substances listed in Annex II above the maximum concentration values. Those limits apply to each homogeneous material, not to the product as a whole.
| Substance | Maximum concentration (by weight in homogeneous material) |
|---|---|
| Lead (Pb) | 0.1 % |
| Mercury (Hg) | 0.1 % |
| Cadmium (Cd) | 0.01 % |
| Hexavalent chromium (Cr VI) | 0.1 % |
| Polybrominated biphenyls (PBB) | 0.1 % |
| Polybrominated diphenyl ethers (PBDE) | 0.1 % |
| Bis(2-ethylhexyl) phthalate (DEHP) | 0.1 % |
| Butyl benzyl phthalate (BBP) | 0.1 % |
| Dibutyl phthalate (DBP) | 0.1 % |
| Diisobutyl phthalate (DIBP) | 0.1 % |
Specific applications can benefit from the exemptions listed in Annexes III and IV, each with its own scope and expiry date.
Meeting the substance limits is only half of the job. Article 7 sets out the manufacturer’s obligations, which include:
- 7(a) – ensure the EEE is designed and manufactured in line with Article 4.
- 7(b) – draw up the technical documentation and carry out internal production control (Module A of Annex II to Decision 768/2008/EC).
- 7(c) – draw up the EU Declaration of Conformity and affix the CE marking.
- 7(d) – have procedures in place so that series production remains in conformity.
- 7(e) – keep the technical documentation and the Declaration of Conformity for 10 years after the EEE is placed on the market.
- 7(f) to 7(j) – keep registers of non-conforming products and recalls, identify the product and the manufacturer, take corrective action and cooperate with national authorities.
In other words, a product that complies with the restriction of substances but does not have a solid technical file is not a compliant product.
EN IEC 63000:2018 – the only harmonised standard for RoHS
EN IEC 63000:2018, Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances, is the current harmonised standard published in the Official Journal under the RoHS Directive. Its reference was published through Commission Implementing Decision (EU) 2020/659 and it fully replaced its predecessor, EN 50581:2012, on 18 November 2021.
It is important to be precise about what it covers. EN IEC 63000 is not a test method and it does not set substance limits. It is a standard about technical documentation. Its Annex ZZ links Clause 4 of the standard to Articles 7(b) and 7(e) of the Directive:
- Article 7(b) – drawing up the technical documentation;
- Article 7(e) – keeping that documentation available for 10 years.
When a manufacturer builds and keeps the technical file in line with Clause 4, there is a presumption of conformity with those two obligations. This is why EN IEC 63000 is the standard referenced in practically every RoHS Declaration of Conformity.
Clause 4 describes a risk-based process. The manufacturer:
- Identifies the materials, components and subassemblies in the product.
- Determines what information is needed for each, based on the likelihood that restricted substances are present and the trustworthiness of the supplier.
- Collects that information: supplier declarations, contractual agreements, material declarations (for example per IEC 62474) or analytical test results (per the IEC 62321 series).
- Evaluates the information and decides whether it is sufficient.
- Reviews the documentation over time, especially when parts, suppliers or the regulation change.
The standard openly recognises that it is impractical for manufacturers of finished electrical and electronic products to test every material in the final assembly themselves. Instead, it lets them rely on information from their supply chain, with testing reserved for where the risk justifies it.
The real challenge: getting the information from suppliers
Relying on supplier information solves the testing problem, but it creates another one: you have to collect that information first.
A simple power adapter may have a few dozen parts. A product such as an EV charger, a solar inverter or an industrial controller can easily have a bill of materials with several hundred line items, sourced from hundreds of different suppliers – manufacturers, distributors, contract assemblers and small local workshops.
In practice, compliance teams run into the same issues again and again:
- Suppliers do not answer, or answer weeks later after several reminders.
- Distributors forward a generic statement instead of the manufacturer’s part-specific declaration.
- Mechanical parts (screws, brackets, labels, cables, plastic housings) are often the hardest to document, because their suppliers are not used to RoHS requests.
- The same component appears under different part numbers across BOM revisions.
- Documents arrive in every format imaginable: PDFs, spreadsheets, website screenshots and e-mails.
Collecting the documents is a project in itself, and it never completely ends: every new part, alternative source or design change brings new requests.
Evaluating the information and building the technical file
Receiving a document is not the same as having evidence. EN IEC 63000 expects the manufacturer to evaluate what it receives, and this is where many technical files fall short. Typical questions for each document are:
- Does it identify the exact part number, or only a product family?
- Does it refer to the current Annex II list, including the four phthalates added by Delegated Directive (EU) 2015/863?
- If it claims an exemption, is that exemption still valid and does it apply to this use?
- Is it signed, dated and issued by someone who can actually vouch for the part?
- For high-risk parts (solders, PVC cables, coatings), is a declaration enough, or are a full material declaration or test results needed?
Once each item has been evaluated, the results need to be brought together in a technical file that a market surveillance authority can follow. A typical RoHS technical file includes:
- A general description of the product and its identification.
- The bill of materials, with the supplier and documentation status of each part.
- The supporting documents, and the evaluation of each one.
- The risk assessment that justifies the type of evidence chosen.
- Any test reports, plus the exemptions relied on.
- The EU Declaration of Conformity.
The file must also stay alive. Design changes, supplier changes, expiring exemptions and new restricted substances all require it to be reviewed, and it has to be kept for 10 years.
Conclusion
EN IEC 63000:2018 gives manufacturers a clear, recognised route to demonstrate RoHS conformity, and it removes the need to test every material in the product. What it does not remove is the work behind the technical file: tracking down information from many suppliers, judging whether that information is good enough, and organising it into documentation that will stand up to scrutiny for 10 years.
How can RoHSorNOT help
Our RoHS Conformity Assessment Documentation service covers the work described above. Starting from your bill of materials, we:
- Search for the existing compliance information for each component, from manufacturers’ and distributors’ published data.
- Contact the suppliers directly to request the missing declarations, material declarations or test reports, and follow up until we get them.
- Review every document as required by EN IEC 63000:2018 and the current Annex II restrictions, including part-number match, validity of exemptions and the risk level of each part.
- Build the technical documentation: a technical report with a collection and evaluation table covering every component, ready to support your EU Declaration of Conformity.
You can find out more at rohsornot.com or contact us at Contact@rohsornot.com.
